The development of the ICIQ-UAB: A patient reported outcome measure for underactive bladder.

AIMS: To present the development of the International Consultation on Incontinence Questionnaire-underactive bladder (ICIQ-UAB) as the first patient reported outcome measure for the assessment of the symptoms and impact on the health-related quality of life of UAB developed in-line with the Food and Drug Administration Guidance for Industry. METHODS: Draft items were developed following 44 semi-structured concept elicitation interviews in the UK and refined using 36 cognitive interviews. A pilot study was designed to assess the draft ICIQ-UAB's initial psychometric properties with 54 patients recruited from European hospitals. Further concept elicitation interviews were also carried out with 11 patients in the US and 10 patients in Japan. All participants had a prior urodynamic diagnosis of detrusor underactivity. RESULTS: The cognitive interviews confirmed the initial items to be understood and interpreted as intended. Pilot testing showed that both internal consistency (Cronbach's α ≥ 0.85) and test-retest reliability (stable patients; intraclass correlation coefficient ≥ 0.88) were high. The interviews in the US and Japan elicited symptoms and impacts that support previous findings in the UK and provided further insight into the experiences of patients in those countries. The developmental ICIQ-UAB was refined using the evidence from all substudies. CONCLUSIONS: The validity and reliability of the ICIQ-UAB were supported in a pilot study setting and the wider cultural applicability by the additional interviews in the US and Japan. Following further validation in future clinical trials, the developmental ICIQ-UAB is envisaged as an important tool for the monitoring of future UAB treatment strategies.

What are the additional signs and symptoms in patients with detrusor underactivity and coexisting detrusor overactivity?

AIMS: This study aimed to determine what difference the inclusion of patients with coexisting detrusor overactivity (DO) makes to the signs and symptoms of patients with detrusor underactivity (DU). METHODS: A total of 250 male and 435 female urodynamic tests were analyzed retrospectively. Signs and symptoms which showed a statistically significant difference between DU without DO and DU with DO were identified. RESULTS: Males with DO in addition to DU had higher age and number of daily micturitions, and were more likely to report urgency with or without urgency incontinence than males with DU without DO. They also had lower volumes for first desire to void, volume voided, and post void residual urine, lower abdominal pressure at Qmax and were less likely to report a history of retention or reduced bladder filling sensation than males with DU without DO. Females with DO in addition to DU had higher age and BMI, and were more likely to report urgency incontinence, higher day and night pad usage, constipation and have reduced anal tone than females with DU without DO. They also had lower volumes for first desire to void, volume voided, and post void residual urine, and lower abdominal pressure at Qmax than females who had DU without DO. CONCLUSIONS: There are differences in signs and symptoms between patients who have DU without DO, compared to patients having DU with DO. This understanding will help future studies investigating treatment options for DU patients.

Signs and symptoms that distinguish detrusor underactivity from mixed detrusor underactivity and bladder outlet obstruction in male patients.

AIMS: This study aimed to identify signs and symptoms which show differences between men with detrusor underactivity (DU) compared to those with both DU and bladder outlet obstruction (BOO). METHODS: One thousand six hundred and twelve urodynamic tests on male patients were analyzed retrospectively. Signs and symptoms which showed a statistically significant difference between patients with DU alone and patients with both DU+BOO were identified. RESULTS: In the DU only group, considering only patients without a history of bladder outlet surgery, the number of daytime micturitions was lower, maximum voided volume on the bladder diary was higher, and slow stream was reported less often, whereas urinary tract infections were reported more often than for DU+BOO males. The average urine flow rate and abdominal pressure at maximum flow were greater in the DU males, compared to the DU+BOO males. CONCLUSIONS: These data suggest that by combining symptoms, medical history and signs, that could be measured without the need for invasive urodynamics, it may be possible to identify men with DU in a non-invasive way. By doing so, men with DU could be separated from men with both DU+BOO, with sufficient specificity to allow the use of any new non-surgical treatment modalities, such as new and effective medical therapy.

Signs and Symptoms of Detrusor Underactivity: An Analysis of Clinical Presentation and Urodynamic Tests From a Large Group of Patients Undergoing Pressure Flow Studies.

BACKGROUND: The clinical diagnosis of detrusor underactivity (DU) is hampered by the need for invasive pressure flow studies (PFS) in combination with a lack of knowledge of the associated signs and symptoms. This has contributed to a lack of awareness of DU and underactive bladder, and to the assumption that symptoms are always due to bladder outlet obstruction (BOO). OBJECTIVE: To investigate the signs and symptoms recorded in a large urodynamic database of patients who met the diagnoses of DU, BOO, and normal, to identify the clinical features associated with DU. DESIGN, SETTING, AND PARTICIPANTS: From the database of 28282 adult PFS records, 1788 patients were classified into: (1) those with DU without BOO; (2) those with BOO without DU; and (3) those with normal PFS. RESULTS: Patients with DU reported a statistically significantly higher occurrence of decreased and/or interrupted urinary stream, hesitancy, feeling of incomplete bladder emptying, palpable bladder, and absent and/or decreased sensation compared with patients with normal PFS. Other differences were found between men with DU and BOO, and between women with DU and normal PFS. CONCLUSIONS: There are signs and symptoms that can distinguish DU patients from patients with normal PFS and further distinguish between DU and BOO, which is traditionally invasively diagnosed. This is a first step to better understand the clinical presentation of DU patients, is consistent with the recent underactive bladder working definition, and justifies further exploration of the signs and symptoms of DU. PATIENT SUMMARY: The clinical diagnosis of detrusor underactivity is hampered by the need for invasive urodynamics in combination with a lack of knowledge of the associated signs and symptoms. This study has shown that there are signs and symptoms that can distinguish men and women patients with DU from patients with either normal urodynamic studies or with BOO.